Colpopexy and Urinary Reduction Efforts (CARE) Protocol

Completed · Phase 3

Conditions studied: Urinary Incontinence, Stress, Uterine Prolapse, Vaginal Prolapse

In brief

Pelvic organ prolapse occurs when the muscles holding pelvic organs (e.g., the uterus or bladder) weaken and the organs fall or slide down into the vagina. Pelvic organ prolapse can be corrected with surgery. However, women who have this surgery may develop urinary incontinence. This study will determine how doctors can predict this problem and whether an additional surgical procedure at the time of prolapse surgery can prevent the development of urinary incontinence.

Key facts

Study ID

NCT00065845

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

322

Starts

2002-04-01

Expected to finish

2007-04-01

Last updated by the study team

2011-01-11

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Eligibility for primary procedure (sacrocolpopexy)
• Eligibility for secondary procedure (Burch colposuspension)
• Stage II-IV anterior vaginal prolapse, defined as POP-Q Point Aa at -1, 0, +1, +2, or +3 cm.
• Negative stress incontinence screen
• Negative stress incontinence screen (MESA questionnaire)

You may not qualify if…

• Contraindication for sacrocolpopexy or Burch colposuspension.
• Anatomic contraindication for Burch colposuspension (i.e., Point Aa fixed at -2 or -3 cm).
• Surgeon judgment that a contraindication to Burch colposuspension exists.
• Anticipated geographic relocation within the first three months after surgery (e.g., within approximately 6 months of screening).
• Inability to provide informed consent or to complete testing or data collection.
• Currently pregnant.

Where it is running

• The University of Alabama at Birmingham — Birmingham, Alabama, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• University of Iowa College of Medicine — Iowa City, Iowa, United States
• Johns Hopkins School of Medicine — Baltimore, Maryland, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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